UMIN-CTR Clinical Trial

Basic information
Public title	Significance of pretreatment EGFR T790M subclones detected by droplet digital PCR on EGFR-TKI efficacy in patients with non-small cell lung cancer (PREDICT-ddPCR) - a multicenter collaborative study- (WJOG13119L)
Acronym	Significance of pretreatment EGFR T790M subclones detected by droplet digital PCR on EGFR-TKI efficacy - a multicenter collaborative study-
Scientific Title	Significance of pretreatment EGFR T790M subclones detected by droplet digital PCR on EGFR-TKI efficacy in patients with non-small cell lung cancer (PREDICT-ddPCR) - a multicenter collaborative study-
Scientific Title:Acronym	Significance of pretreatment EGFR T790M subclones detected by droplet digital PCR on EGFR-TKI efficacy - a multicenter collaborative study-
Region	Japan

Condition
Condition	Non-small cell lung cancer
Classification by specialty	Pneumology Hematology and clinical oncology Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to compare the time to treatment failure of EGFR-TKIs between pretreatment EGFR T790M positive and negative groups detected by droplet digital PCR methods.
Basic objectives2	Others
Basic objectives -Others	Time to treatment failure
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Time to treatment failure of EGFR-TKIs between pretreatment EGFR T790M positive and negative groups detected by dd-PCR methods.
Key secondary outcomes	Time to treatment failure between different generations of EGFR-TKIs in patients with or without pretreatment EGFR T790M detected by dd-PCR. Progression free survival of EGFR-TKIs between pretreatment EGFR T790M positive and negative groups by dd-PCR methods. Examination of the appropriate cut-off value of EGFR T790M allele frequency for the efficacy of EGFR-TKIs. T790M mutation detection ability after acquired resistance between Cobas and dd-PCR methods. T790M mutation allele frequency by dd-PCR methods in pretreatment tumor tissue samples between T790M positive and negative groups by Cobas after acquired resistance.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Pathologically confirmed non-squamous non-small cell lung cancer 2) Confirmed EGFR mutations (exon 19 deletion, exon 21 L858R) in tumor tissue samples taken after April 2015 3) Confirmed EGFR exon20 T790M negative in pretreatment tumor tissue samples 4) Stage III or IV not suitable to radical radiation therapy. Recurrence after operation or chemoradiotherapy. 5) EGFR-TKI treatment naive, previous treatment with at least one chemotherapy regimen 6) Provision of archival tumor tissue obtained prior to EGFR-TKI treatment
Key exclusion criteria	1) Confirmed EGFR exon19 deletion or exon21 L858R plus other EGFR gene mutations 2) Switching to another EGFR-TKI between different generations
Target sample size	360

Research contact person
Name of lead principal investigator	1st name Noboru Middle name Last name Hattori
Organization	Hiroshima University Hospital
Division name	Department of Respiratory Internal Medicine
Zip code	734-8551
Address	1-2-3 Kasumi, Minami-ku, Hiroshima, Japan
TEL	082-257-5196
Email	nhattori@hiroshima-u.ac.jp

Public contact
Name of contact person	1st name Shinichiro Middle name Last name Nakamura
Organization	West Japan Oncology Group
Division name	WJOG datacenter
Zip code	556-0016
Address	Namba Plaza Bldg. 304-1-5-7, Motomachi Naniwa-ku, Osaka, JAPAN
TEL	06-6633-7400
Homepage URL
Email	datacenter@wjog.jp

Sponsor
Institute	West Japan Oncology Group
Institute
Department

Funding Source
Organization	Nippon Boehringer Ingelheim Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethical Committee for Epidemiology of Hiroshima University
Address	1-2-3 Kasumi, Minami-ku, Hiroshima
Tel	082-257-1551
Email	iryo-seisaku@office.hiroshima-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2020 Year 05 Month 25 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	360
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2020 Year 05 Month 23 Day
Date of IRB	2020 Year 06 Month 02 Day
Anticipated trial start date	2020 Year 08 Month 11 Day
Last follow-up date	2021 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Target sample size is 360. (The target sample for each first, second and third generation EGFR-TKI is 120 cases, respectively.)

Management information
Registered date	2020 Year 05 Month 21 Day
Last modified on	2021 Year 10 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046145